Bempedoic Acid

Bempedoic acid is used together with lifestyle changes (diet, weight-loss, exercise) and certain cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins]) to further decrease low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood of adults with familial heterozygous hypercholesterolemia (HeFH; an inherited condition in which cholesterol cannot be removed from the body normally) or heart disease. Bempedoic acid is in a class of medications called adenosine triphosphate-citrate lyase (ACL) inhibitors. It works by blocking the production of cholesterol in the liver.

Bempedoic acid comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take bempedoic acid at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take bempedoic acid exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking bempedoic acid,

• tell your doctor and pharmacist if you are allergic to bempedoic acid, any other medications, or any of the ingredients in bempedoic acid tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: fluoroquinolone antibiotics including ciprofloxacin (Cipro), gatifloxacin (Zymar, Zymaxid), levofloxacin (Levaquin), or ofloxacin; pravastatin (Pravachol); simvastatin (Flolipid, in Vytorin); or oral or injectable steroids such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had gout, tendon (a fibrous tissue that connects a bone to a muscle) problems, or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking bempedoic acid, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Bempedoic acid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • muscle spasms

  • back pain

  • pain in hands or feet

• Some side effects can be serious. If you experience any of these symptoms, stop taking bempedoic acid and call your doctor immediately or get emergency medical treatment:

  • severe pain, redness, warmth, tenderness, or swelling of the joints, especially in the big toe area

  • hearing or feeling a snap or pop in a tendon area; bruising after an injury to a tendon area; or inability to move to or bear weight on affected tendon area

• Bempedoic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with the tablets to absorb moisture) from your bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to bempedoic acid.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Nexlizet^® (containing Bempedoic Acid, Ezetimibe)